Events

Alerte De Sécurité sur loose procell / cleancell aspiration tube filter on modular analytics , cobas e601 and cobas e602

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Roche.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2014-05-26
  • Date de publication de l'événement
    2014-05-26
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140526.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: roche loose procell / cleancell aspiration tube filter on modular analytics , cobas e601 and cobas e602 medical device manufacturer, roche, has issued a field safety notice (fsn) concerning roche loose procell / cleancell aspiration tube filter on modular analytics , cobas e601 and cobas e602. based on recently received complaints, the manufacturer has identified that under certain conditions loose procell /cleancell aspiration tube filters might affect results. when the procell / cleancell bottle is almost empty (the liquid level in the procell / cleancell bottle drops below the joint between aspiration tube and the filter), system reagent foam may be created and aspirated into the measuring cell. in case of procell this can cause discrepant results: high for competitive and low for sandwich assays. the magnitude of the discrepancy varies with the amount of air being aspirated. the manufacturer advises users of the followings: special caution should be taken so that the aspiration tube lifter is not dropped after the replacement of the procell / cleancell bottle. users should check that the procell /cleancell aspiration tube filter is properly tightened. if the procell / cleancell aspiration tube filter is blocked and needs to be cleaned, users should ensure that the filter is properly tighten when placing it back after the cleaning process. there will be a change of the “procell / cleancell aspiration tube filter check” from operator’s maintenance to service maintenance. the operator’s manual will be updated accordingly. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 26 may 2014.

Device

loose procell / cleancell aspiration tube filter on modular analytics , cobas e601 and cobas e602
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Roche Loose ProCell / CleanCell Aspiration Tube Filter on MODULAR ANALYTICS , cobas e601 and cobas e602
  • Manufacturer
    Roche

Manufacturer

Roche